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Cyclobenzaprine treatment for sexual dysfunction

a technology of cyclobenzaprine and sexual dysfunction, which is applied in the direction of sexual disorders, drug compositions, organic active ingredients, etc., can solve the problems of poor compliance, refusal of medication, and inability to treat ptsd,

Pending Publication Date: 2021-10-14
TONIX PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a method for treating sexual dysfunction and associated symptoms in females by administering a pharmaceutical composition containing a therapeutically effective amount of cyclobenzaprine or a pharmaceutically acceptable salt thereof. The method can also involve using a basifying agent, such as potassium dihydrogen phosphate or sodium carbonate, to enhance the solubility and stability of the cyclobenzaprine. The composition can be administered daily or once a day, and can be formulated for various routes of administration such as sublingual, buccal, oral, suppository, intravenous, or nasal. The technical effect of the patent text is to provide a method for effectively treating sexual dysfunction and associated symptoms in females using a pharmaceutical composition containing cyclobenzaprine.

Problems solved by technology

However, treating PTSD does not necessarily resolve symptoms of SD.
In addition, serotonin reuptake inhibitors (SSRIs) and benzodiazepines, commonly prescribed psychiatric medications for the treatment of PTSD, are shown to exacerbate pre-existing SD, as well as contribute to poor compliance and refusal of medication (Keller, McGarvey, Clayton, 2006).

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0136]Effects on Female Sexual Functioning of a Low Dose, Sublingual Formulation of Cyclobenzaprine in Subjects with Military-Related PTSD after 12 Weeks of Treatment

[0137]Methods: In this 12-week, multicenter, adaptive design, randomized controlled fixed-dose trial, 5.6 mg cyclobenzaprine-HCl (2×2.8 mg sublingual tablets, comprising a 75%±2% cyclobenzaprine-HCl and 25%±2% mannitol eutectic and a potassium phosphate dibasic anhydrous basifying agent) taken daily at bedtime was compared to placebo for the treatment of PTSD at 45 U.S. sites. Eligible participants (males and females) were 18-75 years of age, had experienced DSM-5 PTSD Criterion A-qualifying trauma(s) during military service since 2001, met DSM-5-defined PTSD by the Clinician-Administered PTSD Scale (CAPS-5), had a baseline CAPS-5 severity score ≥33, and were free of antidepressants, and free or washed off other psychotropic medications. A pre-planned interim analysis was conducted when about half the originally planned...

example 2

[0142]Effects on Female Sexual Functioning of a Sublingual Formulation of Cyclobenzaprine-HCl in Military and Civilian Phase 3 PTSD Trials: Preliminary Evidence for a Female-Specific Improvement in Sexual Functioning after 12 Weeks

[0143]Three randomized, placebo-controlled and double-blind clinical trials of the above described 5.6 mg cyclobenzaprine-HCl sublingual formulation (2×2.8 mg tablets) were performed, a Phase 2 study and a Phase 3 study in military-related PTSD, and a Phase 3 study in predominantly civilian PTSD. All three trials showed encouraging activity using the 5.6 mg cyclobenzaprine-HCl dose on clinician- and patient-rated global PTSD symptoms (Clinician Global Impression [CGI] and Patient Global Impression of Change [PGIC]). Given the very low rates of adverse events related to sexual function in both drug and placebo groups in the Phase 2 study, a systematic study was undertaken to assess the effects of the treatment on female sexual functioning in subsequent Phas...

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Abstract

The present disclosure provides a pharmaceutical composition comprising therapeutically effective amounts of cyclobenzaprine and one or more agents, and methods of treating and / or preventing sexual dysfunction.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority and benefit from U.S. Provisional Application No. 63 / 007,251, filed Apr. 8, 2020, the contents of which is hereby incorporated by reference in their entirety.BACKGROUND[0002]There is increasing documentation of the comorbidity of sexual dysfunction (SD) and posttraumatic stress disorder (PTSD) among veterans (Letica-Crepulj a et al., 2019). Compared to those without any mental health diagnosis or with a mental health diagnosis other than PTSD, veterans with PTSD are at a higher risk of SD. This is true regardless of chronicity of symptoms, age or other health concerns, suggesting that the mechanisms underlying such dysfunction are directly related to PTSD (Hirsch, 2009). Common types of SD in males include erectile dysfunction, sexual disinterest, and premature ejaculation; whereas common types of SD in females include fear of sex, arousal problems, orgasm problems, sexual disinterest, and vaginal pain. Mo...

Claims

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Application Information

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IPC IPC(8): A61K31/135A61K45/06A61K33/00A61K31/085A61K31/496A61K31/485A61K31/568A61K31/519A61K31/137A61K31/5513A61K31/15A61K31/138A61K9/20A61P15/00
CPCA61K31/135A61P15/00A61K33/00A61K31/085A61K31/496A61K31/485A61K31/568A61K31/519A61K31/137A61K31/5513A61K31/15A61K31/138A61K9/2072A61K9/2018A61K45/06
Inventor PARMENTER, MEGAN ELIZABETHSULLIVAN, GREGORY M.
Owner TONIX PHARMA INC
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